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NCT Number: NCT04378296

Economic Evaluation in Teledermatology

Introduction: Previous studies confirm that teledermatology allows the generation of a quick response from the specialist's consultation, reduction of unnecessary travels, early diagnosis and priority in the attention to the most urgent cases. Despite these advantages and that teledermatology has experienced exponential growth since its introduction approximately 16 years ago in Spain, in Andalusia, its use is still very limited. The objective of this project will be to carry out an analysis of the quality of life related to health, costs, cost-utility and informal care of teledermatology services in Primary Care compared to conventional monitoring carried out at the Hospital de Poniente.

Methodology: A randomized, controlled, unmasked, inter-level clinical trial (Primary Care-Hospital de Poniente) and multicentre (all health centers attached to the Poniente Health District of Almería) will be carried out with a 6-month follow-up. Patients will be assigned to the teledermatology group (experimental) or the conventional monitoring group in the hospital (control). The patients included in the experimental group will be monitored asynchronously. Baseline characteristics, number of visits to the hospital, health-related quality of life, costs, informal care and satisfaction from the perspective of the Andalusian Public Health System and patients and their caregivers will be analyzed. The generic EuroQol-5D questionnaire (EQ-5D) will be administered to assess health-related quality of life and the SKINDEX-29 quality of life dermatological questionnaire. A cost-utility analysis will be performed to assess whether tele-dermatology is cost-effective in terms of additional cost for additional quality-adjusted life years (QALYs).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Poniente, El Ejido, Almeria, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Be over 18 years old.
  • 2. Having any skin disease.
  • 3. Accept to participate in the study.

Exclusion criteria

  • 1. Non-dermatological disease.
  • 2. Be participating in another study.
  • 3. Refuse to participate in the study.

Treatment and study plan

Teledermatology

Other

The experimental group will be made up of dermatological patients monitored asynchronously.

Primary outcomes

  1. EuroQol-5Dimensions questionnaire

    Time frame: 6 months

    From -1 [the poorest imaginable health state] to 1 [perfect health]

Secondary outcomes

  1. Clinical features

    Time frame: 6 months

    Patient's age; sex; diagnosis; origin; indication (type of dermatological problem); number of visits

  2. Dermatological Quality of Life Questionnaire

    Time frame: 6 months

    0 (no effect on quality of life) up to 100 (maximum effect on quality of life)

  3. Healthcare costs

    Time frame: 6 months

    Costs paid by the Public Health System

  4. Informal cost

    Time frame: 6 months

    Costs paid by the patients

  5. In-depth interviews on the healthcare received in Primary Care centers

    Time frame: 6 months

    • healthcare center, 2) procedure to make an appointment, 3) medical consultation, 4) nursing consultation
  6. Health Care Communication Questionnaire

    Time frame: 6 months

    The 5-point Likert scale, ranging from 1 (not at all) to 5 (very much).

Sponsors and collaborators

Lead sponsor

Antonio Lopez Villegas

Other

Collaborators

  • Universidad de Almeria

Registry information

Official study title

Economic Evaluation in Dermatology: Teledermatology Versus Conventional Monitoring of Patients in the Hospital

Acronym: TELEDERMA

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 7, 2020
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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